Bicalutamide
- Product NDC
- 62559-890
- 11-digit product format
- 625590890
- Labeler code
- 62559
- Product ID
- 62559-890_cf149c3a-84aa-4ef8-befc-1dbeb7dcc678
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bicalutamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA020498
- Marketing category
- NDA
- Marketing start
- 2020-10-26
- Substance
- BICALUTAMIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bicalutamide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BICALUTAMIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A0Z3NAU9DP |
| Rxcui | 199123 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-890-30 | Bicalutamide | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-890 | BICALUTAMIDE TABLET [ANI PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231220_7a08d88b-051a-4c16-9560-12685c500c58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62559-890-30 | 62559089030 | 30 TABLET in 1 BOTTLE (62559-890-30) | 30 tablet | 2020-10-26 | 0000-00-00 | No | No | Current |